Trial document




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  DRKS00000736

Trial Description

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Title

Establishment of a biomarker for development and incidence of postoperative ileus

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Trial Acronym

Bipoi

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Postoperative ileus is a common complication after abdominal surgery leading to nausea, vomiting and breathing problems. In rare cases multiorgan failure could be observed.
The aim of our trial is to establish a laboratory parameter to predict the development and the degree of severity of postoperative ileus. Therefore a prophylactic transfer to an intensiv care unit could be performed before severe complications would arise

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Brief Summary in Scientific Language

Postoperative ileus (POI) is a frequent and severe complication after intestinal surgery. Bowel dysmotility can last for days and necessitates parenteral nutrition, leads to risk of aspiration and to infectious complications. POI is linked with a high economic burden. The resulting costs exceed US$ 1 billion per year.
Our previous studys could demonstrate that an inflammatory cascade is initiated by macrophages of the tunica muscularis of the small bowel. Unfortunately the inflammation spreads over the whole gastrointestinal tract via migrating Th1-cells leading to severe inflammation of the whole intestinal wall with development of postoperative ileus.
Until today, predictive factors whether patients develop postoperative ileus or about the extent of illness are lacking.
The aim of our study is to establish a laboratory parameter for postoperative ileus to prevent severe complications in the future.

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Organizational Data

  •   DRKS00000736
  •   2011/08/05
  •   [---]*
  •   yes
  •   Approved
  •   065/11, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   K91.3 -  Postoperative intestinal obstruction
  •   K56.0 -  Paralytic ileus
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Interventions/Observational Groups

  •   Laparotomy
  •   Thoracotomy or surgery on peripher blood vessels
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Diagnostic
  •   Other
  •   N/A
  •   [---]*
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Primary Outcome

1. quantity of Th1-cells in peripheral blood (60 min, 3h, 6h and 24 h after starting of the operation
2. Dissolution of postoperative Ileus, evaluated by a questionnaire (checking first flatus, first defecation, return to solid food...).

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Secondary Outcome

None

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/10/01
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

Surgery including abdominal incision, thoracic incision or surgery on vascular vessels, signed informed consent, 18 years and older

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Exclusion Criteria

reoperation within 24 h after primary operation, lack of informed consent,

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Addresses

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    • Universitätsklinikum Bonn Klinik und Poliklinik für Allgemein-, Viszeral-, Thorax- und Gefäßchirurgie
    • Sigmund Freud Straße 25
    • 53115  Bonn
    • Germany
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    • Klinik und Poliklinik für Allgemein-, Viszeral-, Thorax- und Gefäßchirurgie, Universitätsklinikum Bonn
    • Mr.  Dr. med.  Tim  Vilz 
    • Sigmund Freud Straße 25
    • 53105  Bonn
    • Germany
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    • Klinik und Poliklinik für Allgemein-, Viszeral-, Thorax- und Gefäßchirurgie, Universitätsklinikum Bonn
    • Mr.  Dr. med.  Tim   Vilz 
    • Sigmund Freud Straße 25
    • 53115  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.